This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatment finasteride
Phase phase 4
Sponsor Hospices Civils de Lyon
Start date December 2004
Trial size 90 participants
Trial identifier NCT00130767, 2003.316


The aim of this study is to evaluate the mechanisms involved in the apoptosis induced by a treatment of finasteride on benign prostate hyperplasia (BPH). Five sets of patients who need a surgical procedure because of low tract urinary symptoms are randomly attributed to one of five sets of treatment: 0, 7, 14, 21 or 28 days of finasteride treatment before the day of the procedure. Prostate histological fragments are conditioned for molecular and histologic studies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Date of the maximum apoptosis in the prostate tissues treated by finasteride
time frame:

Secondary Outcomes

Molecular mechanisms involved in BPH finasteride induced apoptosis
time frame:
Decrease in the frequency of the hemorrhagic incidents after the surgical procedure in patients with a treatment using finasteride
time frame:

Eligibility Criteria

Male participants from 40 years up to 90 years old.

Inclusion Criteria: - Patients with low tract urinary symptoms needing a surgical procedure - No previous treatment with finasteride - No androgen deficiency; no prostate cancer suspected.

Additional Information

Official title Kinetics of the Finasteride Prostate Induced Apoptosis
Principal investigator Alain RUFFION, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.